While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system.
Jazz Pharmaceuticals plc has patented sulfonamides acting as orexin OX2 receptor agonists reported to be useful for the treatment of hypersomnia, narcolepsy and sleep disorders.
Orexia Therapeutics Ltd. has divulged 2-(3-ethynylbenzyl)-substituted heterocycle derivatives acting as orexin OX2 receptor agonists reported to be useful for the treatment of narcolepsy, hypersomnia, insomnia and sleep apnea.
Tohoku University has divulged quinoline compounds acting as histamine N-methyltransferase (HNMT) inhibitors reported to be useful for the treatment of narcolepsy, Alzheimer's disease and attention deficit hyperactivity disorder (ADHD).
Little more than a month after selling a narcolepsy drug from its portfolio, Jazz Pharmaceuticals plc has replaced it with another. The company entered an exclusive development and commercialization rights agreement Sumitomo Pharma Co. Ltd.’s candidate for treating narcolepsy along with idiopathic hypersomnia and other sleep disorders. Sumitomo retains the rights for Japan, China and certain other Asia-Pacific countries and regions while Jazz gets the rights to everywhere else.
Harmony Biosciences Holdings Inc.’s plan disclosed at the start of last December to launch a phase III study with Wakix (pitolisant) for idiopathic hypersomnia (IH) during the first half of this year brought renewed attention to the sleep space, where a handful of players are jostling for position.
Aculys Pharma Inc. closed its $60 million series A financing round, with the funds to be used to develop pitolisant (Wakix), a selective histamine H3 receptor antagonist/ inverse agonist, in Japan.
Investors clipped shares of Avadel Pharmaceuticals plc recently as anxieties rose over the application by Jazz Pharmaceuticals plc for a patent that relates to a once-nightly oxybate product that could threaten the prospects for Avadel’s FT-218.
The FDA has approved Xywav (calcium, magnesium, potassium and sodium oxybates; JZP-258), an oxybate product for treating both cataplexy and excessive daytime sleepiness in narcolepsy patients ages 7 and older, from Jazz Pharmaceuticals plc.
